Submission Details
| 510(k) Number | K040095 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 20, 2004 |
| Decision Date | March 05, 2004 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
Mar 2004
Decision
45d
Days
Class 2
Risk
About This 510(k) Submission
K040095 is an FDA 510(k) clearance for the IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 5, 2004, 45 days after receiving the submission on January 20, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.
Device Classification
| Product Code | MVM — Autoantibodies, Endomysial(tissue Transglutaminase) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
Manufacturer
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